KR102213286B1 - Medicinal herbs composition for treating vaginitis and preventing Cervical intraepithelial neoplasia - Google Patents

Abstract

The present invention relates to an herbal medicine composition for treating vaginitis and preventing uterine cervical dysplasia. More specifically, the present invention contains a hot water extract of a mixture including Coix lachryma-jobi var. mayuen, Atractylodes lancea, Dictamnus dasycarpus, and Sophora flavescens as an active component. The herbal medicine composition according to the present invention has an advantage of effectively preventing uterine cervical dysplasia by effectively treating and preventing bacterial vaginosis and Candida vaginitis. In addition, the herbal medicine composition has no toxicity or side effects, and has excellent safety, thereby being able to be used as herbal preparations, pharmaceuticals, and health foods.

Description

Herbal medicine composition for treating vaginitis and preventing Cervical intraepithelial neoplasia}

The present invention relates to an herbal composition for the treatment of vaginitis and the prevention of cervical dysplasia, and more specifically, by effectively treating vaginitis, preventing humanpapillomavirus (HPV) infection, and cervical intraepithelial neoplasia CIN It relates to an herbal composition for the treatment of vaginitis preventing the occurrence and prevention of cervical dysplasia.

More than 90% of vaginitis that occurs in women of childbearing age are bacterial vaginosis, candidal vaginosis, and trichomonas vaginitis, of which 40-50% are bacterial vaginosis. These bacteria cannot proliferate when the inside of a woman's vagina is normal, but easily invade when the body is not normal due to overwork, stress, or taking contraceptives, increasing complications such as infection after surgery, and even obstetrically Since complications such as early labor may occur, care should be taken and effective treatment should be performed.

The female vagina is naturally colonized by a variety of bacteria, yeasts and microorganisms. For example, a normal woman's vagina typically contains about 10 ⁴ or more Lactobacillus spp per milliliter of vaginal material. Under normal conditions, the vaginal flora provides a weakly acidic environment that helps protect against the invasion of pathogenic microorganisms.

However, under normal conditions as described above, the vaginal flora, that is, vaginal equilibrium, can be easily overturned by various external factors that ultimately induce vaginal infection. Vaginal infection is a clinical syndrome and mainly bacterial vaginosis, Candida vaginitis, and Trichomonas vaginitis have been reported. Among these, the most common vaginitis is bacterial vaginosis.

The bacterial vaginosis is reported to be mainly caused by an increase in the number of anaerobic organisms accompanied by a decrease in lactic acid bacteria in the vagina.In addition, it can be caused by bacterial or viral infections, taking antibiotics or contraceptives, and using excessive vaginal cleansing agents. It is reported to be. Decreasing the number of lactic acid bacteria in the vagina decreases competition for nutrients, increases the pH by reducing the amount of lactic acid present, and proliferation of opportunistic pathogens whose growth is normally inhibited in the vagina. It is caused by this.

It has been reported that the major pathogen associated with bacterial vaginosis caused by the proliferation of the above pathogens is Gardnerella vaginalis. Symptoms of bacterial vaginosis caused by infection of the Gardnerella vaginalis generally have a characteristic unpleasant odor in cold, and cold enough to wet underwear, vaginal secretions, that is, watery, homogeneous secretions, and vaginal pH Rises above about 50, itching occurs, and includes the presence of Gardnerella crue cells, vaginal epithelial cells coated with Gram-carriing bacillus. The vagina is a 7~9cm long tube that is connected to the cervix from the external genitalia. The entrance to the vagina is located in the middle of the urinary tract and anus, and acts as an excretory passage for substances secreted from the cervix. Various bacteria are normally inhabiting the vagina of adult women, including Lactobacillus, Streptococcus, and Staphylococcus. The inhabitation ratio between anaerobic and aerobic bacteria is about 5:1, and in about 20% of women, the fungus Candida is normally found in the vagina. The type of inhabited strain is affected by the content of glycogen and glucose in the vagina, and the pH.

The normal vaginal pH is 45-51. The reason why the interior of the vagina is acidic is that the vaginal bacteria and vaginal epithelial cells produce lactic acid using glycogen and glucose. Lactobacillus living in the vagina plays a useful role in suppressing the reproduction of harmful bacteria by maintaining the pH by producing lactic acid.

Bacterial vaginosis is the most common cause of vaginal inflammation, and it is not clear whether it is infected through sexual intercourse. However, there are reports that bacterial vaginosis is related to sexually transmitted diseases such as gonorrhea and chlamydia infection. Bacterial vaginosis is caused by over-proliferation of anaerobic bacteria among normal bacteria in the vagina due to a decrease in the propagation degree of lactic acid bacteria among normal bacteria in the vagina. The causative strains include Gadnerella vaginalis, Peptostreptococcus, Mobiluncus, and Bacteroides. Typical symptoms include an increase in vaginal discharge and a color (white or pale yellow, green, gray, etc.) and a fishy odor. The characteristic odor is caused by aromatic amines produced by overgrown bacteria.

A lot of research has been done on a vaginitis treatment method to prevent and treat such vaginitis. Recently, as a treatment method for a bacterial infection of the vagina, a method of administering a vaginitis treatment such as metronidazole orally or in the form of a cream has been generally used. However, the use of broad-spectrum antibiotics such as metronidazole not only implies the problem of antibiotic resistance, but also the use of such antibiotics is evaluated as undesirable because it can kill a wide range of normal bacteria in the vagina including beneficial lactic acid bacteria. Has become.

On the other hand, it has been reported that the killing of normal vaginal flora including these lactic acid bacteria may cause secondary complications. In other words, the decrease of lactic acid bacteria that inhibit various opportunistic pathogens in the vagina increases the pH in the vagina, making it difficult to maintain an acidic environment, and thus accelerates infection by anaerobic bacteria proliferation and may cause additional infection.

As an example, frequent infection of the bacterial vaginosis may be the cause of cervical dysplasia (CIN), and the cervical dysplasia is a precancerous lesion of cervical cancer, mainly due to infection with human papillomavirus (HPV). And, such HPV infection may be caused by secondary complications due to the death of the normal flora in the vagina.

Therefore, it is urgent to develop a safe vaginitis prevention or treatment composition that effectively prevents the CIN and HPV, suppresses and/or treats vaginal infection, and does not have side effects.

KR 10-2014810 B1 KR 10-1771479 B1 KR 10-1133723 B1

An object of the present invention is to provide an herbal composition comprising a mixed extract of Uiyiin, Jeonju, Baekseonpi and Gosam, thereby antibacterial against Staphylococcus aureus and antifungal activity against Candida albicans. It is to provide an herbal composition for the treatment of vaginitis and prevention of cervical dysplasia to effectively prevent and treat.

Another object of the present invention is to provide an herbal composition for treating vaginitis and preventing cervical dysplasia, which can effectively prevent cervical dysplasia by effectively preventing and treating vaginitis.

The herbal composition for the treatment of vaginitis and the prevention of cervical dysplasia of the present invention for achieving the above object is characterized in that it comprises a hot water extract of a mixture of Ui-in, Jeon, tinea and Gosam as an active ingredient.

The hot water extract is mixed with 100 parts by weight of the above, 50 to 70 parts by weight of creation, 30 to 40 parts by weight of Baekseonpi, and 30 to 40 parts by weight of Gosam, and then 3 to 24 at 50 to 130°C using water as a solvent. It is characterized by time extraction.

The herbal composition is characterized by having an antibacterial activity against Staphylococcus aureus and Gardnerella vaginalis and an antifungal activity against Candida albicans.

The herbal composition according to the present invention has the advantage of being able to effectively prevent cervical dysplasia by effectively treating and preventing bacterial vaginosis and candidal vaginitis. In addition, there is no toxicity or side effects, and excellent safety, so it has the advantage that it can be used as a herbal medicine preparation, medicine, and health food.

The present invention is intended to illustrate and describe specific embodiments as various changes may be made and various embodiments may be provided. However, this is not intended to limit the present invention to a specific embodiment, it is to be understood to include all changes, equivalents, or substitutes included in the spirit and scope of the present invention.

Hereinafter, the present invention will be described in detail.

The present invention relates to an herbal composition for the treatment of vaginitis and the prevention of cervical dysplasia, comprising a hot water extract of a mixture of Ui-in, Cheong, Baekseonpi and Gosam as an active ingredient.

The uiyiin used in the present invention is a peeled egg of the adlay fruit, has an effect of smoothing the body's water metabolism, and is known to play a role in helping the digestive system. In addition, pharmacological actions such as anti-tumor, anti-glycemic, immunity enhancement, intestinal uterine inhibition, sedation, pain relief, and fever are known.

The creation is by drying the root fruit of Sapju, which is known to strengthen the stomach and prevent obesity. It is also known to be effective in removing poison and pain in the body.

The ringworm peel is dried root bark of ringworm ringworm, and is used for skin rash, eczema, rubella, itching, allergic dermatitis, etc., and antipyretic action and fungal inhibitory action have been reported.

The gosam is a dried root of gosam, and antibacterial, anti-inflammatory, and diuretic effects have been reported.

The herbal composition of the present invention comprises an extract obtained by extracting hot water from a mixture of the above ingredients as an active ingredient, and specifically, 100 parts by weight of Ui-in, 50 to 70 parts by weight of creation, 30 to 40 parts by weight of Baekseonpi and 30 of Gosam After mixing ~40 parts by weight, the extract, which is extracted with water as a solvent, at a temperature of 50 to 130°C under normal pressure or pressurization, for 3 to 24 hours is included as an active ingredient. At this time, the mixing ratio is for the complementary action of each component. In addition, it is natural that the extract can be filtered, concentrated or dried as necessary, and further implementation thereof is not limited.

The herbal composition of the present invention has an antibacterial activity against Staphylococcus aureus and Gardnerella vaginalis and Candida albicans ( It has antifungal activity against Candida albicans) to effectively prevent and treat vaginitis in women.

On the other hand, in order to further increase antibacterial activity against Staphylococcus aureus and Gardnerella vaginalis and antifungal activity against Candida albicans, the Ui-in, creation, ringworm And 1 to 10 parts by weight of areca palm and 1 to 10 parts by weight of fig tree may be further mixed with the mixture of Gosam to extract hot water.

The Areca palm (Chrysalidorcarpus lutescens) is an air-purifying plant, which is a kind of palm without thorns, and uses dried leaves, thereby imparting more excellent antibacterial and antifungal activity.

In addition, the fig tree is the dried leaves of the fig tree, and the fig tree also imparts more excellent antibacterial and antifungal activity.

The herbal composition according to the present invention can be used as a pharmaceutical composition.

The pharmaceutical composition may further include ingredients that are commonly used in pharmaceutical compositions to improve odor, taste, and vision. In addition, the pharmaceutical composition of the present invention may additionally contain a pharmaceutically acceptable additive. Pharmaceutically acceptable additives include, for example, starch, gelatinized starch, microcrystalline cellulose, lactose, povidone, colloidal silicon dioxide, calcium hydrogen phosphate, lactose, mannitol, syrup, gum arabic, pregelatinized starch, corn starch, powdered cellulose, Hydroxypropyl cellulose, Opadry, sodium starch glycolate, carnaubanap, synthetic aluminum silicate, stearic acid, magnesium stearate, aluminum stearate, calcium stearate, sucrose, dextrose, sorbitol and talc, etc., but are not limited thereto.

The pharmaceutical composition of the present invention may contain a pharmaceutically acceptable carrier and may be formulated for oral use. When formulating the pharmaceutical composition of the present invention, diluents or excipients such as fillers, extenders, binders, wetting agents, disintegrants and surfactants may be used.

In addition, the dosage of the pharmaceutical composition of the present invention can be varied depending on the patient's age, physical condition, weight, etc., but can be generally taken 2 to 5 times a day in an amount of 0.1 to 1000 mg/kg per day. have.

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Hereinafter, the present invention will be described in more detail through examples.

(Example 1)

Uiiin 100 parts by weight, creation 60 parts by weight, tinea skin 35 parts by weight, and gosam 35 parts by weight were prepared, washed with purified water, dried, and then powdered. Then, after preparing a mixture by mixing these medicinal materials, 10 times the amount of water was added thereto, and hot water extraction was performed at 90°C for 3 hours. And the obtained extract was filtered.

(Example 2)

As medicinal materials, 10 parts by weight of dry leaf powder of Areca palm and 10 parts by weight of dry leaf powder of fig tree were further used.

(Test Example 1): Cytotoxicity

The MTT solution forms formazan by mitochondrial dehydrogenases in living cells to confirm the survival of cells.

In order to confirm the cytotoxicity of the samples prepared in Examples 1 and 2, MTT (3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide) analysis was performed. At this time, the samples of Examples 1 and 2 were concentrated and lyophilized.

Specifically, RAW 2647 cells were seeded in a 96-well plate at 1×10 ⁴ cells/well, and then cultured to 70% confluency. Then, the samples dissolved in DMSO were treated at concentrations of 50, 100, 300, 500 and 1000 µg/ml, respectively, and cultured for 24 hours. Then, MTT reagent (0.2 mg/ml) was added. After culturing for an additional 2 hours, the culture medium was removed, 100 µl of dimethylsulfoxide was added, and the absorbance was measured at 540 nm with a microplate reader (Genios, Tecan, Austria) to determine cell viability. Was determined.

As a result, it was confirmed that Examples 1 and 2 did not affect cell viability up to 500 μg/ml.

(Test Example 2): Antibacterial and antifungal effects by the disk diffusion method

In order to confirm the antibacterial and antifungal effects of the samples prepared in Examples 1 and 2, the disc diffusion method was performed on the vaginal infection strain. At this time, the samples of Examples 1 and 2 were concentrated and lyophilized.

Specifically, the inhibitory activity was measured using the disclosed disc fusion method using Staphylococcus aureus, Candida albicans, and Gardnerella vaginalis. Inhibitory activity was inoculated to 10 ⁶ CFU in KEPCO medium and each sample was injected to be 0.5% (w/w), and then the size of the inhibitory ring was measured, and the results are shown in Table 1 below.

Test Example 2 result division Size of suppression ring (mm)_after 24 hours Staphylococcus aureus Candida albicans Gardnerella parangalis bacteria Example 1 36 25 31 Example 2 40 28 35 Control 15 10 12

As described above, Examples 1 and 2 according to the present invention are expected to have a greater effect of preventing and treating vaginitis by confirming that the inhibitory activity of the strain is greater than that of the control group in which nothing is added to the medium.

(Test Example 3)

The composition of Example 1 was tested on 19 women suffering from chronic vaginitis (when vaginitis symptoms appear more than 3 times a year).

As a prescription, 120ml of the composition of Example 1 was taken twice a day (after breakfast and dinner) for 60 days, and after 6 months, the presence or absence of vaginitis was investigated.

The results are shown in Table 2 below.

Test Example 3 result Patient number Prescription symptoms After prescription One At the end of monthly menstruation, he is diagnosed with vaginitis or bacterial vaginosis. Severe itching. Even at the end of menstruation, symptoms of vaginitis such as itching do not occur. 0 2 Diagnosed with cervical dysplasia, frequent vaginitis, itching, itching, more than 3 times a year, so much that the underwear gets wet. Itching, itching, and discharge from vaginitis disappear many symptoms 0 3 Monthly vaginitis causes swelling and itching of the vulva, and a lot of white radish comes out. Diagnosed positive for HPV. Disappearance of vaginitis symptoms 0 4 Frequent vaginitis, itching, itching, more than 3 times a year, so much secretions that the underwear gets wet, frequent urination Itching, itching, and discharge of many symptoms due to vaginitis 0 5 Vaginitis, originally a lot of cold, itching and burning during menstruation. I usually wear a panty liner every day. You don't have to go without the liner, symptoms go away, then symptoms appear again One 6 Dysplasia stage 1, usually getting wet due to frequent vaginitis, symptoms about once every two months Vaginitis without discharge, lasting more than 2 months, high risk of dysplasia disappeared 0 7 Fibroids and frequent vaginitis cause itching more than twice a month, soreness before menstruation, and secretions even when not in ovulation, so use 4,5 small pads a day. Itching, itching symptoms disappear 0 8 Vaginitis, itching, itching, wet discharge, polycystic ovary Vaginitis symptoms disappeared and maintained for more than 3 months 0 9 Stage 1 dysplasia (no cytology yet), frequent vaginitis, monthly wet discharge, itching, itching occasionally. Uterine fibroids 2 cm. Maintained for more than 6 months without vaginitis symptoms, normal diagnosis of dysplasia 0 10 Elapsed, frequent vaginitis-?Dida bacteria, a lot of secretions enough to get wet. Itching, itching. Endometriosis Maintaining no symptoms of vaginitis for at least 3 months 0 11 Frequent vaginitis, more than 3 times a year, too much secretion to wet underwear, and diagnosed with cervical dysplasia Disappearance of vaginitis symptoms 0 12 Menstrual irregularities, frequent vaginitis, sore, itchy, and a lot of discharge, cervical dysplasia stage 2 was diagnosed and cone resection was performed. Even after surgery, vaginitis symptoms repeat, itching, itching, and discharge from vaginitis are almost eliminated. Itching, itching, and discharge from vaginitis almost disappear 0 13 Polycystic ovary, itchy vulva due to frequent vaginitis, HPV positive Itching of the vulva due to vaginitis disappears 0 14 Frequent vaginitis, candida, gadrella, very severe discharge Although improved, symptoms reappeared, and the symptoms were repeated. One 15 Frequent urination, vaginitis, itching, itching Frequent urination improved a lot, but vaginitis symptoms were recurring One 16 Menstrual period, frequent vaginitis, so much that the panties become wet Reduced discharge from vaginitis 0 17 Once a month, vaginitis continues to recur, itchy and cold, and candida. Gardnera, diagnosed with ureaplasma. Slight improvement, but symptoms persist One 18 Polycystic ovary, frequent vaginitis, severe itching Vaginitis itching symptoms disappear 0 19 Frequent vaginitis, abundant discharge. Guardrenella, urea plasma cultivation Vaginitis discharge many symptoms disappear 0 1: Has symptoms of vaginitis
0: No symptoms of vaginitis

As can be seen in Table 2, after taking Example 1 out of 19 patients, it was confirmed that the symptoms disappeared in 15 patients, and the treatment rate was about 78.94%.

(Test Example 4)

The composition of Example 1 was tested on 10 women diagnosed with cervical dysplasia. As a prescription, 120ml of the composition of Example 1 was administered twice a day (after breakfast and dinner) for 60 days, and after 6 months, the treatment of cervical dysplasia was investigated.

The results are shown in Table 3 below.

Test Example 3 result Patient number Before treatment After treatment One HPV genotyping HPV high risk group 33 detected High-risk HPV virus not detected
Cervicography

2 Diagnosis H-SIL/CIN3 L-SIL/CIN1 HPV genotyping HPV high risk group detected 16 times High-risk HPV virus not detected
3 Cell Pathology Diagnosis Report CIN1

No abnormal findings of epithelial cells 4 Liquid cell pathology diagnosis CIN1

Negative 5 Liquid cell pathology diagnosis L-SIL

ASC-US HPV genotyping HPV high risk group 52.56.66 positive 52 positive HPV high risk group 6 Liquid cell pathology diagnosis ASC-US

Negative 7 HPV genotyping HPV high risk group 31 positive High-risk HPV virus not detected Liquid cell pathology diagnosis ASCUS No abnormal findings of epithelial cells 8 Histopathology diagnosis report CIN3 CIN1 9 HPV genotyping HPV high risk group No. 16 positive High-risk HPV virus not detected Liquid cell pathology diagnosis HSIL/CIN3 ASCUS 10 Liquid cell pathology diagnosis CIN2

No abnormal findings of epithelial cells

As can be seen in Table 3, Example 1 according to the present invention was confirmed to be effective in the treatment and prevention of cervical dysplasia.

As described above, the present invention has been described with reference to preferred embodiments of the present invention, but those skilled in the art can variously modify and change the present invention within the scope not departing from the spirit and scope of the present invention described in the following claims. You will understand that you can do it.

Claims (3)

It contains as an active ingredient a hot water extract of a mixture of Uiyiin, Chunjin, Baekseonpi, Gosam, Areca palm, and Fig tree,
The hot water extract is a mixture of 100 parts by weight of the uiyiin, 50 to 70 parts by weight of creation, 30 to 40 parts by weight of Baekseonpi, 30 to 40 parts by weight of Gosam, 1 to 10 parts by weight of Areca and 1 to 10 parts by weight of fig tree Then, the herbal composition for the treatment of vaginitis and the prevention of cervical dysplasia, characterized in that it is extracted for 3 to 24 hours at 50 to 130 °C using water as a solvent.
delete The method of claim 1,
The herbal composition,
Treatment of vaginitis and prevention of cervical dysplasia, characterized by having antibacterial activity against Staphylococcus aureus and Gardnerella vaginalis and antifungal activity against Candida albicans Chinese herbal medicine composition.